Uterine Scar RemodelingNCT02338388
Cesarean-scar Thickness and Closure Technique
A study testing cesarean section technique in people with Uterine Scar Remodeling, run by Christian Bamberg.
Trial summary
The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar Remodeling
- What is being tested?
- cesarean section technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Elective cesarean section
- Cesarean section during labor
Who cannot join
- Emergency cesarean section
- Declined to participate
About this study
Official title: Longitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study
The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.
Read the detailed description
The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery.
The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer.
Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI).
The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.
- Conditions
- Uterine Scar Remodeling
- Being tested
- cesarean section technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section techniqueProcedure or surgery
Comparing three different types of suturing the uterus at Cesarea section
| Study group | Role | What they receive |
|---|---|---|
| Single-layer unlocked closure | Active comparator | Not described Receives: Procedure: cesarean section technique |
| Single-layer locked closure | Active comparator | Not described Receives: Procedure: cesarean section technique |
| Double-layer closure | Active comparator | The first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture. Receives: Procedure: cesarean section technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
cesarean scar-thickness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Scar RemodelingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Bamberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Bamberg, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338388
- Sponsor's protocol ID
- (EA1/149/11)
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bamberg C, Hinkson L, Dudenhausen JW, Bujak V, Kalache KD, Henrich W. Longitudinal transvaginal ultrasound evaluation of cesarean scar niche incidence and depth in the first two years after single- or double-layer uterotomy closure: a randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Dec;96(12):1484-1489. doi: 10.1111/aogs.13213. Epub 2017 Sep 21.
PubMed 28832909
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02338388
- Acronym / sponsor ID
- (EA1/149/11)
- Conditions
- Uterine Scar Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Christian BambergUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.
Detailed description
The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery.
The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer.
Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI).
The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-layer unlocked closure | Active comparator | Procedure: cesarean section technique |
| Single-layer locked closure | Active comparator | Procedure: cesarean section technique |
| Double-layer closure | Active comparator | Procedure: cesarean section techniqueThe first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Elective cesarean section
- Cesarean section during labor
Key exclusion criteria (2 listed)
- Emergency cesarean section
- Declined to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cesarean section techniqueComparing three different types of suturing the uterus at Cesarea section | Procedure or surgery | Double-layer closure, Single-layer locked closure, Single-layer unlocked closure |
Primary outcome
cesarean scar-thickness
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Derived from this study: PubMed 28832909Bamberg C, Hinkson L, Dudenhausen JW, Bujak V, Kalache KD, Henrich W. Longitudinal transvaginal ultrasound evaluation of cesarean scar niche incidence and depth in the first two years after single- or double-layer uterotomy closure: a randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Dec;96(12):1484-1489. doi: 10.1111/aogs.13213. Epub 2017 Sep 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cesarean section technique in people with Uterine Scar Remodeling, run by Christian Bamberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cesarean scar-thickness (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.